Hemostatic Agents with Thrombin and Fibrin Sealant

Notice of Intent to Sole Source

The Naval Medical Center San Diego (NMCSD) intends to award a sole source purchase order under the authority of FAR 13.106-1(b), due to only one source being available to meet the Government's needs, to Ethicon, Rte 22 W, Somerville, NJ 08876-0000. Requirement is 20 boxes of (Surgiflo) hemostatic agent 8mL with thrombin and 75 boxes of (Evicel) 5mL Kit (10mL) Fibrin Sealant. The first hemostatic agent is used in both open and laparoscopic cases. It must be a thrombin-based sealant and provide a minimum of 8mL of total product volume upon mixing/preparation for use. Product must be able to be used in less than 1 minute from reconstitution. Product must be human formulation, with no bovine or porcine biologics. The second hemostatic agent is used in both open and laparoscopic cases. It must be a fibrin-sealant and provide a minimum of 10mL of total product volume upon mixing/preparation for use. Product must be able to be used in less than 1 minute from refrigeration storage. Product must be human formulation, with no bovine or porcine biologics. Requirement is set up with multiple delivery options to supply FY16.

Ethicon is the only vendor that provides a thrombin-based sealant with 8mL and fibrin-based sealant with 10mL of total product volume upon mixing/preparation for use. This is the only hemostatic agents on the market that meets the requirements identified herein. Additionally, this is the only product on the market of its kind.

This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 5 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source purchase order.

Capability statements are due by 10:00 AM Local Time, March 12, 2016. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: merlinda.m.labaco.civ@mail.mil.